A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT05718570
- Status
- Enrolling By Invitation
Conditions
- Adult Growth Hormone Deficiency
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Somapacitan — DRUGSogroya therapy in participants with AGHD.
Study Details
In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.
Key Dates
- Start date
- Feb 3, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 15, 2032
- Completion
- Dec 15, 2032
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: Participants with Adult Growth Hormone Deficiency (AGHD)Participants will be treated with commercially available Sogroya according to routine clinical practice at the discretion of the treating physician. The decision to treat a participant with Sogroya has been made prior to and independently from the decision to include the participant in this study.
Primary Outcome Measure
Number of Adverse drug reaction (ADRs) [ Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) ]
Locations (29)
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